Inotuzumab Ozogamicin injection

What is this medicine?

INOTUZUMAB OZOGAMICIN (in oh tooz oo mab oh zoe ga my sin) is a monoclonal antibody and a chemotherapy drug. It is used to treat acute lymphoblastic leukemia.

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation

• decreased appetite

• diarrhea

• headache

• stomach pain

• tiredness

• vomiting

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cisapride

• dofetlide

• dronedarone

• pimozide

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

What if I miss a dose?

Keep appointments for follow-up doses as directed. It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• irregular heartbeat

• liver disease

• low blood counts caused by a medicine

• low levels of calcium, magnesium, or potassium in the blood

• an unusual or allergic reaction to inotuzumab ozogamicin or other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. You may need blood work done while you are taking this medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Do not become pregnant while taking this medicine or for at least 8 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for at least 5 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for at least 2 months after stopping it.

This medicine may interfere with the ability to have a child. Talk with your doctor or health care professional if you are concerned about your fertility.